Next Generation Electro Membrane Extraction (EME) for Sample Preparation

A paradigm shift is expected from the major players in sample processing because there are so many different solutions/protocols that are used today. Almost all the methods are based on the sample being "filtered" through several processes and thus there is a risk of losing the sample, with consequent uncertainty around the analysis answer, which actually determines life or death in extreme cases. The project has developed a sample processing technology for basic and acidic drugs in blood that revolutionizes current sample processing within clinical analyses. The technology uses conductive plastic materials in a vial form (sample container) that is identical to current industry standards, this choice is motivated by our desire to lower the threshold for it to be put into use. After extraction, the drugs are in pure pH-adjusted water. This is instrument friendly and cost-saving for advanced instrumentation that has very expensive service agreements. Several scientific articles have been published which show that the technology is as good as or better than existing technology. The technology scores on international "green" ratings, and it provides close to 100% recovery of drugs from blood, while not being destructive to the sample. The sample can thus be analyzed again if necessary, and this is unique. The technology is protected by three granted patents, and a patent application has been prepared for the 96 well format. The project results have led to the selection of a suitable conducting material, geometry of the vials for which two sizes of 100 uL and 300 uL have been developed. A 12-position commercial instrument will be completed in January 2024 and will be launched in Q2 2024. The instrument is assembled from components from Norwegian companies and two companies from European countries. A PhD degree will be obtained 8.December 2023. The thesis has been accepted.

Scientifically the project has “produced” one PhD, 4 articles in per reviewed journals, and several presentations in media (articles) and at conferences (oral presentations). Commercially GTS, through its daughter company Extraction Technologies Norway AS (ETN), will finalize the instrument in January 2024 through subcontractors. All needed consumables are produced by industrial partners in Norway and other European countries. The first product will be a kit containing the instrument and needed consumables, and it will be presented during Analytica in Munich 9-12.April 2024. Sale will start immediately after this exhibition. ETN has held one soft capital raise in August 2022, and plan for a new one in January 2024. Then there are plans for attracting one or more external investors during Q1-Q2. The mother company GTS established a new daughter company named G&T Septech LLC in Pennsylvania, USA in December 2022. GTS has filed a “petition for a nonimmigrant worker” (I-129) with the USCIS. GTS has sold technology and competence for packing miniaturized HPLC columns to a Xxxx owned subsidiary in Pennsylvania, USA and Roger Trones is already in the process of fulfilling the contract that runs until 31.December 2024. In parallel he is working on a route for funding a US operation that will be responsible for the commercial introduction of the EME instrument (kit) in the US market. NDA is in place with Actuated Medical https://actuatedmedical.com/ for qualifying the instrument for the US market, and initial discussions with Ben Franklin Technology Partners https://cnp.benfranklin.org/ related to funding have started.

Electromigration of ions across an oil membrane is termed Electromembrane Extraction (EME). G&T Septech AS (GTS) is commercializing this Norwegian invention as a sample preparation technology under an exclusive license. The original novel idea is to use electricity to migrate charged drug molecules from the donor solution in a glass vial, through a supported hydrophobic liquid membrane (SLM), to the water solution of the acceptor vial. GTS was industrializing this initial idea, by patenting and prototyping conductive polymer EME vials. The main objective is to deliver reproducible and improved conductive EME vials, instrumentation, and SLMs, for future target molecules. To design those vials, GTS needs to optimize the mass transfer through the membrane by modeling the current flow. In addition, optimal conductive materials and a manufacturing process of EME-instrumentation for single, 96w & 384w EME vials will be selected. For extraction of e.g. peptides, carbohydrates, and nonpolar biomolecules, new types of supported liquid membranes with protocols must be invented. One of the most critical R&D challenges is to model the electric field distribution through the SLM to get the best vial design. The next challenge is to optimize membranes for the next generation of targets by focusing on the desired physical and chemical properties of the SLMs. Sample preparation still remains a significant bottleneck in research, crucial to the success of downstream applications. EME can efficiently extract drug molecules from dirty samples, typically from urine, blood and saliva samples, and it is suited for the high throughput sample preparation market. The potential of this market is worth 7.2 Bn USD by 2021. EME may improve the sample preparation for both HPLC/GC and the new acoustic mist ionization-MS techniques and reduces the maintenance costs of those instruments. It gives a clean extract from complex solutions, being non-destructive for the original sample.